REG - Sareum Holdings PLC - Dosing of first subjects in MAD Phase 1a trial

Sareum HoldingsAnnouncement

04/09/2023 07:00

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RNS Number : 1921L  Sareum Holdings PLC  04 September 2023

 Sareum Holdings PLC

("Sareum" or the "Company")

Sareum starts dosing first subjects in the multiple ascending dose part of
Phase 1a clinical trial for SDC-1801

Cambridge, UK, 4(th) September 2023 - Sareum Holdings plc (AIM: SAR), a
clinical-stage biotechnology company developing next generation kinase
inhibitors for autoimmune disease and cancer, today announces the successful
dosing of the first subjects in the multiple ascending dose part of its Phase
1a clinical trial for lead programme SDC-1801. Dosing has started at a
specialist clinical unit in Melbourne, Australia, and subjects will receive
SDC-1801 orally once daily for 10 days.

This follows approval by the safety review committee granted upon review of
preliminary data generated from the initial three cohorts in the single
ascending dose part of the study. The committee deemed these data as
satisfactory for the multiple ascending dose part of the study to commence, as
well as for continued dose escalation in the single ascending dose part of the
study.

SDC-1801 is a dual TYK2/JAK1 kinase inhibitor being developed as a potential
new therapeutic for a range of autoimmune diseases with an initial focus on
psoriasis, an autoimmune condition affecting the skin.

The Phase 1a trial is designed to investigate the safety, tolerability,
pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in
healthy subjects (trial ID ACTRN12623000416695p). This is a randomised,
placebo-controlled trial with single and multiple ascending oral dose studies.
This trial includes a single ascending dose study (Part 1), a multiple
ascending dose study (Part 2) and a food effects study (Part 3).

The safety and pharmacokinetics data from the initial cohorts in Part 1 of the
trial indicate a favourable profile and fully support oral dosing of patients
once daily. Full safety data from the Phase 1a trial are expected to be
available during the first half of 2024 and, provided satisfactory results are
obtained, a Phase 1b clinical study is expected to commence as soon as
possible thereafter in psoriasis patients.

Dr Tim Mitchell, CEO of Sareum, commented:

"We are delighted that the data generated to date supports the safety review
committee's approval to begin dosing the first subjects in the multiple
ascending dose part of our Phase 1a trial of SDC-1801. Of particular
importance are the pharmacokinetics findings demonstrating that patients will
be able to receive SDC-1801 orally once daily. During this next phase of the
study, we expect valuable biomarker data to be generated, that will be
available upon completion of this part of the trial.

"As SDC-1801 continues to progress through the clinic on schedule, we remain
committed to bringing this innovative medicine to patients with autoimmune
disease. We look forward to the completion of the Phase 1a study and to
progression into Phase 1b, subject to continuing positive safety results in
the remainder of the Phase 1a."

-Ends-

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                   01223 497700

 Lauren Williams, Head of Investor Relations         ir@sareum.co.uk

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                         020 7409 3494

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel / Patrick Birkholm                      020 7418 8900

 Hybridan LLP (Joint Corporate Broker)

 Claire Noyce                                        020 3764 2341

 Consilium Strategic Communications (Financial PR)

 Jessica Hodgson / Davide Salvi / Stella Lempidaki   020 3709 5700

About Sareum

Sareum Holdings (AIM:SAR) is a clinical-stage biotechnology company developing
next generation kinase inhibitors for autoimmune disease and cancer.

The Company is focused on developing next generation small molecules which
modify the activity of the JAK kinase family and have best-in-class potential.
Its lead candidate, SDC-1801, simultaneously inhibits TYK2 and JAK1. SDC-1801
is a potential treatment for a range of autoimmune diseases and has entered
Phase 1a/b clinical development with an initial focus on psoriasis.

Sareum has an economic interest in SRA737, a clinical-stage Chk1 inhibitor
which it originally developed in collaboration with several Cancer Research
UK-related organisations. SRA737 has shown promising safety and efficacy in
two Phase 1/2 clinical trials.

Sareum is also developing SDC-1802, a TYK2/JAK1 inhibitor with a potential
application for cancer immunotherapy.

Sareum Holdings plc is based in Cambridge, UK, and is listed on the AIM market
of the London Stock Exchange, trading under the ticker SAR. For further
information, please visit the Company's website at www.sareum.com
(about:blank)

 

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